The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Tina-quant [a] Crp.
| Device ID | K871895 |
| 510k Number | K871895 |
| Device Name: | TINA-QUANT [A] CRP |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Cheri Emmons |
| Correspondent | Cheri Emmons BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-15 |
| Decision Date | 1987-06-15 |